UNKNOWN

FEED

Primary Responsibilities: Creates required clinical trial documents including clinical protocols, investigator brochures, DSURs and clinical modules of the IND (in concert with Study Medical Directors)Works closely with Clinical Operations to execute the clinical trial with high quality and according to timelinesPerforms ongoing review of clinical data, query generation/resolution and data analysis, including review of draft listings to support data cleaning and interpretationProvides scientific expertise to Clinical Operations by responding to questions and/or by clarifying issues arising during study conductProvides internal safety monitoring for clinical trials in collaboration with the Study Medical DirectorProvides medical input for the clinical database build, CRFs, monitoring plan, data management plan, safety monitoring plan and statistical analysis planDevelops and maintains relationships with clinical trial investigators and therapeutic area key opinion leadersLeads review of study data (e.g., tables, listings and figures and emerging bioanalytical data) and develops CSRs, clinical presentations and publicationsSupports other members of Clinical Development and Regulatory Affairs departments as requiredParticipates as a standing member of multidiscipline Project TeamsAdheres to all department and company-wide policies regarding conduct, performance and proceduresPerforms other duties as required. Ability to work independently and prioritize multiple tasks and goals to ensure timely, on-target and within-budget accomplishmentsExcellent written and oral communication skills and interpersonal skillsAbility to adjust style/contents to suit the audience/purposeSelf-starter, highly motived, highly organized and hands on with outstanding attention-to-detailAbility to demonstrate competencies applicable for job based on Xencor's Leadership Competency Model.

YEAR

Xencor, Inc.

Associate Director, Clinical Science (Autoimmune)

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Develop external relationships and strategic partnerships by building and maintaining effective linkages, relationships, and feedback and communication loops between scientists or project teams involved in the conduct of science and external scientific or academic bodies. Whether collaborating with more than 200 highly respected physicians nationwide or partnering with colleagues who are passionate about solving meaningful problems, you’ll be surrounded by a team committed to shared success.

US Fertility

Associate Laboratory Director

Contributes or reviews clinical, regulatory, and relevant study documents, including Investigator Brochures, Clinical Study Reports, Statistical Analysis Plans, Operation Manuals, Investigational New Drug Applications/Clinical Trial Applications, case report forms, and data tables listings and figures. Excellent teamwork and negotiation skills: knows how to complete deliverables by working effectively with others internally and externally; can effectively drive discussions and decisions toward desired end results.

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